A study to assess effects (how safe and effective) of HM61713 (new medicine) on specific type of non-small cell lung cancer, which characterized by being positive to certain type of mutation (T790M) , after treatment with a class of drugs known as (EGFR-TKI). The study will also test the drug concentrations´changes in the patient blood at certain time points.

Phase 1

• Conditions: on-small cell lung cancer (NSCLC); MedDRA version: 18.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001435-21-ES
• Lead Sponsor: Hanmi Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-03
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Provide written informed consent before any study-specific procedures (including special Screening tests) are performed.
2. At least 20 years of age at the time of signing informed consent.
3. Cytologically or histologically confirmed, locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy.
4. Radiologically confirmed disease progression following:
a. 1st line EGFR-TKI treatment without further anticancer treatment in the intervening period before the first administration of start drug OR
b. Prior therapy with a platinum-based doublet chemotherapy and with an EGFR-TKI in any sequence. Patients may have received additional lines of anticancer treatment.
5. Documented EGFR mutations which are known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q).
6. World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months.
7. Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen.
8. At least one lesion (excluding the brain), not previously irradiated and not chosen for biopsy during the study Screening period, that can be accurately measured per RECIST version 1.1.
9. Adequate hematological and biological function as follows:
a. Absolute neutrophil count (ANC) >/= 1.5 x 109/L; hemoglobin >/= 9.0 g/dL; platelets >/= 100 x 109/L without the use of hematopoietic growth factors.
b. Total bilirubin c. Creatinine d. Albumin >/= 2.5 g/dL.
e. Aspartate transaminase (AST) and alanine transaminase (ALT) f. Amylase g. Potassium and magnesium 10. Females of child-bearing potential (not surgically sterilized and between menarche and one-year post-menopause) must agree to use adequate contraception (one of the following listed below) during the study (both men and women as appropriate) and for 3 months after the last dose of study drug.
Patients who are not surgically sterilized must have a negative urine or serum pregnancy test completed during the Screening period. The following measures need to be followed for females of child-bearing potential:
a. Total abstinence from sexual intercourse as the preferred lifestyle of the patient.
b. Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
c. Intra-uterine device (IUD).
11. Male patients should be documented to be sterile or agree to use barrier contraception i.e. condoms.
12. Recovery to Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713.
2. Treatment with any of the following:
a. Anticancer therapies including chemotherapy, hormonal treatment, or immunotherapy within 14 days of the first administration of study drug.
b. Treatment with an EGFR-TKI (including erlotinib, gefitinib, and afatinib) within 10 days or 5-fold half-life, whichever is the longer, of the first administration of study drug.
c. Previous treatment with HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type EGFR (e.g. AZD9291, CO-1686).
d. Treatment with any investigational agent(s) within 28 days prior to the first administration of study drug.
e. Radiotherapy with wide-field or more than 30% of the bone marrow within the past 2 weeks prior to the first administration of study drug; localized palliative radiation (e.g. localized skeletal metastasis) is permitted.
f. Current treatment with medications with known potential to prolong the QT interval which cannot be discontinued or switched to alternate medication prior to the first administration of study drug.
g. Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug, except those related to this study.
h. Current use of any drugs known as strong inducers or inhibitor of CYP2D6 or CYP3A4, unless the use is terminated before >/=1 week of the first administration of study drug.
3. Spinal cord compression, leptomeningeal carcinomatosis or other untreated or symptomatic brain metastases; patients with treated brain metastases are eligible if stable for at least 4 weeks without the requirement for steroids or anti-epileptic therapy.
4. History of any other malignancy (other than curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors Ta [non-invasive tumor] and TIS [carcinoma in situ]) unless it has been definitively treated with no ongoing therapy or evidence of relapse or recurrence within the past 3 years.
5. Clinically significant uncontrolled condition(s), including but not limited to:
a. Refractory nausea and vomiting, inability to swallow the formulated product, or any gastrointestinal disorder, which may interfere with the administration or metabolism of the study drug.
b. Active infection that requires parenteral antibiotics.
c. Known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C.
d. Psychiatric illness/social situations that would limit compliance with study requirements.
e. Known or suspected substance abuse or alcohol abuse.
f. Any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities.
6. Pancreatitis within the past 6 months prior to the date of the first administration of study drug.Pancreatic assessment must be within normal limits at Screening Visit.
7. Any of the following cardiac abnormalities or history:
a. Abnormal 12-lead ECG considered to be clinically significant by the investigator.
b. QT interval corrected using Fridericia´s (QTcF) or Bazett´s (QTcB) method > 450 msec.
c. Personal or family history of long QT syndrome, second or third degree heart block.
d. Implanted pacemaker or cardioverter defibrillator.
e. Resting bradycardia < 55 beats/min.
f. Uncontrolled hypertension.
8. Presence or history of interstitial lung disease (ILD), drug-induced ILD, or r

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified